U.S. patent number 9,044,541 [Application Number 11/566,620] was granted by the patent office on 2015-06-02 for pressure activated proximal valves.
This patent grant is currently assigned to C. R. Bard, Inc.. The grantee listed for this patent is William R. Barron, Daniel B. Blanchard, Kelly B. Powers. Invention is credited to William R. Barron, Daniel B. Blanchard, Kelly B. Powers.
United States Patent |
9,044,541 |
Blanchard , et al. |
June 2, 2015 |
Pressure activated proximal valves
Abstract
A medical device is disclosed comprising a diaphragm having at
least one slit valve disposed therein, and a valve housing
configured to secure the diaphragm at a peripheral portion of the
diaphragm, wherein a central portion of the diaphragm is positioned
relative to the peripheral portion of the diaphragm such that
compressive forces acting on the peripheral portion of the
diaphragm create moment forces which bias the slit valve in a
closed position. A method is disclosed for using the device in
connection with a catheter for regulation of fluids to and from a
patient.
Inventors: |
Blanchard; Daniel B.
(Bountiful, UT), Powers; Kelly B. (North Salt Lake, UT),
Barron; William R. (Riverton, UT) |
Applicant: |
Name |
City |
State |
Country |
Type |
Blanchard; Daniel B.
Powers; Kelly B.
Barron; William R. |
Bountiful
North Salt Lake
Riverton |
UT
UT
UT |
US
US
US |
|
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Assignee: |
C. R. Bard, Inc. (Murray Hill,
NJ)
|
Family
ID: |
37810342 |
Appl.
No.: |
11/566,620 |
Filed: |
December 4, 2006 |
Prior Publication Data
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Document
Identifier |
Publication Date |
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US 20070161940 A1 |
Jul 12, 2007 |
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Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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60741578 |
Dec 2, 2005 |
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61M
25/0075 (20130101); A61M 39/22 (20130101); A61M
5/16881 (20130101); A61M 39/223 (20130101); F16K
15/147 (20130101); A61M 1/0062 (20130101); A61M
25/0693 (20130101) |
Current International
Class: |
A61M
5/00 (20060101) |
Field of
Search: |
;604/6.1,167.04,30,247,256,167.01,167.03,246,31,533,537,905
;137/843,844,846,847,849 |
References Cited
[Referenced By]
U.S. Patent Documents
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85308118 |
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EP |
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89311584 |
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Nov 1989 |
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EP |
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1954343 |
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Aug 2008 |
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EP |
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966137 |
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GB |
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2217433 |
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GB |
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52118356 |
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JP |
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52118357 |
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Oct 1977 |
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JP |
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54-52312 |
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JP |
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54-52313 |
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Apr 1979 |
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JP |
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61155410 |
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JP |
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63-11817 |
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Jan 1988 |
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JP |
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01034840 |
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Feb 1989 |
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JP |
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2-213354 |
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Aug 1990 |
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JP |
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WO8000923 |
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Nov 1979 |
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WO |
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WO8300049 |
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Jun 1982 |
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WO |
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WO8403838 |
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Mar 1984 |
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WO |
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Other References
CN 200680042508.1 filed Dec. 4, 2006 Office Action dated Apr. 6,
2010. cited by applicant .
CN 200680042508.1 filed Dec. 4, 2006 Office Action dated Sep. 18,
2009. cited by applicant .
EP 0683819.6 filed Dec. 4, 2006 Office Action dated Apr. 14, 2010.
cited by applicant .
EP 0683819.6 filed Dec. 4, 2006 Office Action dated May 6, 2009.
cited by applicant .
PCT/US2006/046216 filed Dec. 4, 2006 International Preliminary
Report on Patentability dated Jun. 4, 2008. cited by applicant
.
PCT/US2006/046216 filed Dec. 4, 2006 Search Report dated Jun. 6,
2007. cited by applicant .
PCT/US2006/046216 filed Dec. 4, 2006 Written Opinion dated Jun. 6,
2007. cited by applicant .
Uchiyama, Manabu et al, Nonlinear Buckling Simulations of Imperfect
Shell Domes using a Hybrid Finite Element Formulation and the
Agreement with Experiments, Fourth International Colloquium on
Computation of Shell & Spatial Structures, 14 pages,
Chania-Crete, Greece, Jun. 5-7, 2000. cited by applicant .
Zhiming, Ye, Nonlinear Analysis and Optimization of Shallow Shells
of Variable Thickness, printed from
http://www.shu.edu.cn/journal/vol1no2199705.htm. cited by applicant
.
CA 2,626,335 filed Dec 4, 2006 Examiner's Report dated Aug. 13,
2012. cited by applicant .
CN 200680042508.1 filed Dec. 4, 2006 Office Action dated Mar. 29,
2012. cited by applicant.
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Primary Examiner: Sirmons; Kevin C
Assistant Examiner: Hayman; Imani
Attorney, Agent or Firm: Rutan & Tucker, LLP
Parent Case Text
CROSS-REFERENCE TO RELATED APPLICATION
This application claims the benefit of U.S. Provisional Application
No. 60/741,578, entitled "PRESSURE-ACTIVATED PROXIMAL VALVES,"
filed Dec. 2, 2005, which is incorporated herein by reference in
its entirety.
Claims
What is claimed is:
1. A pressure-activated valve for regulating fluid flow through a
catheter comprising: a valve for selectively accommodating flow of
liquid through the catheter, the flow of a first liquid passing in
one direction through a central slit in response to a first
pressure differential and the flow of a second liquid in an
opposite second direction through a first lateral slit in response
to a second pressure differential, the second liquid including at
least one body fluid, the valve including a dome-shaped portion
having the central slit disposed thereon, a first lateral region
adjacent a first side of the dome-shaped portion having the first
lateral slit disposed thereon, and a peripheral portion; and a
valve housing configured to secure the peripheral portion of the
valve.
2. The medical device of claim 1, wherein a second lateral slit is
disposed on a second lateral region of the valve adjacent a second
side of the dome-shaped portion.
3. The medical device of claim 2, wherein the central slit, first
lateral slit, and second lateral slit are substantially parallel to
one another.
4. A medical system comprising: a medical device configured to
infuse a first fluid into a patient's body and to aspirate a second
fluid from the patient's body; a diaphragm having at least two
unidirectional slit valves disposed therein, including a first
unidirectional slit valve that is structurally configured to
actuate to allow flow of the first fluid through the medical device
in a distal direction in response to infusion-induced pressures and
to remain closed when subjected to aspiration-induced pressures,
and a second unidirectional slit valve that is structurally
configured to actuate to allow flow of the second fluid through the
medical device in a proximal direction in response to
aspiration-induced pressures and to remain closed when subjected to
infusion-induced pressures; and a valve housing securing the
diaphragm at a peripheral portion of the diaphragm.
5. The medical system of claim 4, wherein the first unidirectional
slit valve is located in a center of the diaphragm, and the second
unidirectional slit valve is adjacent the peripheral portion of the
diaphragm.
6. The medical system of claim 4, wherein the diaphragm also
includes a third unidirectional slit valve that is configured to
actuate only in a proximal direction in response to
aspiration-induced pressures and to remain closed when subjected to
infusion-induced pressures, wherein the third unidirectional slit
valve is separated from the first unidirectional slit valve and the
second unidirectional slit valve.
7. The medical system of claim 6, wherein the first unidirectional
slit valve, the second unidirectional slit valve, and the third
unidirectional slit valve are substantially parallel to one
another.
8. The medical system of claim 4, wherein the diaphragm comprises a
generally dome-shaped portion and an annular peripheral
portion.
9. The medical system of claim 8, wherein the generally dome-shaped
portion does not collapse when subjected to aspiration-induced
pressures.
10. The medical system of claim 4, wherein a central portion of the
diaphragm is positioned relative to the peripheral portion of the
diaphragm such that when the peripheral portion is secured by the
valve housing, compressive forces acting on the peripheral portion
of the diaphragm create moment forces which bias the first
unidirectional slit valve in a neutral position.
11. The medical system of claim 4, wherein the first unidirectional
slit valve actuates at a first infusion-induced pressure and the
second unidirectional slit valve actuates at a second
aspiration-induced pressure that is greater than the
infusion-induced pressure.
12. The medical system of claim 11, wherein the first
unidirectional slit valve actuates at the first infusion-induced
pressure that is less than approximately 2 psi and the second
unidirectional slit valve actuates at the second aspiration-induced
pressure that is greater than approximately 2 psi.
13. The medical system of claim 4, wherein the first unidirectional
slit valve and the second unidirectional slit valve are not
contiguous.
14. The medical system of claim 4, wherein the diaphragm comprises
a generally dome-shaped portion and a lateral region located
between the generally dome-shaped portion and the peripheral
portion of the diaphragm secured by the valve housing, the first
unidirectional slit valve located in the generally dome-shaped
portion, and the second unidirectional slit valve located in the
lateral region.
15. The medical system of claim 4, wherein an outer portion of the
diaphragm has a first thickness that is different from a second
thickness of an inner portion of the diaphragm.
16. The medical system of claim 4, wherein an outer portion of the
diaphragm is thicker than an inner portion of the diaphragm.
17. The medical system of claim 4, wherein the diaphragm further
comprises a reinforced area.
18. The medical system of claim 4, wherein the diaphragm further
comprises at least one slit valve secondary sealing surface.
19. The medical system of claim 4, wherein a surface area of a
proximal portion of the diaphragm subject to fluid pressure is
greater than a surface area of a distal portion of the diaphragm
subject to fluid pressure.
20. A medical device comprising: a catheter configured to infuse a
first liquid into a patient's body and to aspirate a second liquid
from the patient's body; a diaphragm having at least two
unidirectional slit valves disposed therein, including a first
unidirectional slit valve that actuates to allow liquid to flow
from a proximal end to a distal end of the catheter at a first
liquid-induced pressure, and a second unidirectional slit valve
that actuates to allow liquid to flow from the distal end to the
proximal end of the catheter at a second liquid-induced pressure
different from the first liquid-induced pressure, wherein the
second unidirectional slit valve is separated from the first
unidirectional slit valve; and a valve housing securing the
diaphragm at a peripheral portion of the diaphragm.
Description
BACKGROUND
In medicine, an embolism occurs when an object (the embolus, plural
emboli) migrates from one part of the body (through circulation)
and causes a blockage of a blood vessel in another part of the
body. Blood clots form a common embolic material. Other possible
embolic materials include fat globules (a fat embolism), air
bubbles (an air embolism), septic emboli (containing pus and
bacteria), or amniotic fluid. Emboli often have more serious
consequences when they occur in the so-called "end-circulation"
areas of the body that have no redundant blood supply, such as the
brain, heart, and lungs. Assuming normal circulation, a thrombus or
other embolus formed in a systemic vein will always impact in the
lungs, after passing through the right side of the heart. This
forms a pulmonary embolism that can be a complication of deep-vein
thrombosis.
Embolism can be contrasted with a "thrombus" which is the formation
of a clot within a blood vessel, rather than being carried from
elsewhere. Thrombus, or blood clot, is the final product of the
blood coagulation step in hemostasis. It is achieved via the
aggregation of platelets that form a platelet plug, and the
activation of the humoral coagulation system (i.e., clotting
factors). A thrombus is physiologic in cases of injury, but
pathologic in case of thrombosis. A thrombus in a large blood
vessel will decrease blood flow through that vessel. In a small
blood vessel, blood flow may be completely cut-off resulting in the
death of tissue supplied by that vessel. If a thrombus dislodges
and becomes free-floating, it becomes an embolus.
Some of the conditions in which blood clots develop include atrial
fibrillation (a form of cardiac arrhythmia), heart valve
replacement, a recent heart attack, extended periods of inactivity
(see deep venous thrombosis), and genetic or disease-related
deficiencies in the blood's clotting abilities.
Preventing blood clots reduces the risk of stroke, heart attack and
pulmonary embolism. Heparin and warfarin are often used to inhibit
the formation and growth of existing blood clots, thereby allowing
the body to shrink and dissolve the blood clots through normal
methods (see anticoagulant). Regulating fluid flow through
catheters can help minimize embolism and health risks associated
therewith.
BRIEF SUMMARY
One aspect of the present invention discloses a medical device
comprising a diaphragm having at least one slit valve disposed
therein and at least one valve control member. The term
"diaphragm," as used herein, can be defined as any membranous part
that divides or separates. The valve control member can be
configured to cover at least a portion of the diaphragm without
covering any portion of the slit valve and can be further
configured to control deflection of the diaphragm. In another
aspect of the invention, the valve control member comprises at
least one arm extending from an outer portion of the valve control
member to an inner portion of the valve control member. In still
another aspect of the invention, the valve control member comprises
a plurality of arms extending from an outer portion of the valve
control member to a center portion of the valve control member.
Further, the medical device can comprise a valve housing having the
diaphragm therein, the valve housing being configured to be
attached to an elongated tubular member, the elongated tubular
member configured for at least partial placement into a portion of
a patient. In another aspect of the invention, at least a portion
of the slit valve has a nonlinear orientation. In another aspect of
the invention the slit valve further comprises a plurality of
interconnected linear slits oriented in different directions.
In another embodiment, a medical device for regulating fluid flow
comprises a diaphragm having a slit valve disposed therein and a
valve housing configured to secure the diaphragm at a peripheral
portion of the diaphragm. A distal end of the valve housing can be
further configured to attach to a proximal end of an elongated
tubular member, such as a catheter. A central portion of the
diaphragm is positioned relative to the peripheral portion of the
diaphragm such that compressive forces acting on the peripheral
portion of the diaphragm create moment forces which bias the slit
valve in a neutral position. In one aspect of the invention, an
outer portion of the diaphragm is thicker than an inner portion of
the diaphragm. Alternatively, in another aspect of the invention,
an outer portion of the diaphragm is thinner than an inner portion
of the diaphragm. In still another aspect of the invention, the
diaphragm may be substantially circular or substantially oval. In
an additional embodiment of the invention, at least a portion of
the diaphragm approximates the shape of a dome structure. In one
aspect, the diaphragm further comprises a concave or convex annular
member which circumscribes the dome structure. In one embodiment,
the diaphragm is oriented substantially perpendicular to a
direction of flow through the valve housing. In another embodiment,
the diaphragm is oriented at an obtuse angle relative to a
direction of flow through the valve housing. In one aspect, the
diaphragm narrows from a lateral portion of the diaphragm to an
opposite lateral portion of the diaphragm. In still another aspect,
at least two slit valves are installed on opposing sides of the
diaphragm.
In another embodiment, the diaphragm of the medical device further
comprises at least one protruding member on a proximal end of the
diaphragm configured to assist the slit valve to return to the
biased neutral position. In one aspect, the diaphragm further
comprises a pair of centrally located opposing protruding members
on a proximal end of the diaphragm configured to assist the slit
valve to return to the biased neutral position.
One embodiment of the invention contemplates a medical device
comprising a diaphragm with at least one slit valve disposed
therein. The proximal surface and distal surface of the diaphragm
approximate a dome structure. The diaphragm is configured such that
a portion of the proximal end of the diaphragm contiguous with the
slit valve is thinner than an adjacent portion of the diaphragm. In
one aspect, the diaphragm is secured at a peripheral portion by a
valve housing, a distal end of the valve housing being configured
to attach to a proximal portion of an elongated tubular member. In
another aspect, the height of the peripheral portion of the
diaphragm is greater than the height of the dome structure of the
diaphragm at the apex of the dome structure of the diaphragm. In
yet another aspect, the height of the peripheral portion of the
diaphragm is approximately twice the width of the peripheral
portion of the diaphragm. In another embodiment, the peripheral
portion of the diaphragm is compressed by the valve housing
approximately five to 15 percent. In another embodiment, a central
portion of the diaphragm is subjected to moment forces from
compression of the peripheral portion of the diaphragm thereby
biasing the slit valve in a neutral position. In still another
embodiment, a central portion of the diaphragm is positioned at a
proximal end of the peripheral portion of the diaphragm.
In another embodiment of the present invention, a medical device
comprises a cylindrical member having a proximal end configured to
be secured at a peripheral portion by a valve housing, wherein the
peripheral portion has a circumference greater than the
circumference of the main cylindrical member. The medical device
further comprises at least one slit valve placed on an outer wall
of the cylindrical member. The slit valve is oriented parallel to a
longitudinal axis of the cylindrical member. In one aspect, a
distal end of the valve housing is configured to attach to a
proximal end of an elongated tubular member, wherein a distal
portion of the elongated tubular member is configured to be placed
within a portion of a patient.
In a further embodiment, a medical device comprises a
pressure-activated valve having an open circular proximal end and
an at least partially closed distal end. The medical device is
further configured such that the distal end comprises at least a
partially planar surface having at least two slits oriented in
different directions disposed therein. The slits have at least one
common intersection and are configured to actuate in a distal
direction in response to a first pressure differential. The medical
device is further configured such that a portion of the distal end
of the valve is defined by an interior angle of the intersecting
slits, an outer portion of the distal end of the valve tapering
from the distal end of the valve towards the proximal end of the
valve thereby forming a channel on the outer portion of the distal
end of the valve. In one aspect, the medical device further
comprises at least one proximal-actuating slit valve installed on
the distal end. The slit valve is configured to actuate in a
proximal direction in response to a second pressure differential.
In this aspect, the second pressure differential is greater than
the first pressure differential. In another aspect, the slits
placed in the distal end of the valve are oriented to approximate
the shape of a cruciform thereby separating the distal end of the
valve into quadrants. In one aspect, the valve is further
configured such that the center of the cruciform is approximately
collinear with the center of the circular proximal end of the
valve. In yet another aspect, the at least one proximal-actuating
slit valve is placed in a bottom portion of the channel.
In an additional embodiment, a method is disclosed comprising the
steps of placing a distal end of a catheter into a vasculature of a
patient, wherein a proximal end of the catheter has a medical
device connected thereto. The medical device comprises a diaphragm
having at least one slit valve disposed therein and a valve housing
configured to secure the diaphragm at a peripheral portion of the
diaphragm. A central portion of the diaphragm is positioned
relative to the peripheral portion of the diaphragm such that
compressive forces acting on the peripheral portion of the
diaphragm create moment forces which bias the slit valve in a
neutral position. The method further comprises the steps of
creating a first liquid pressure differential across the slit valve
thereby infusing liquids into the patient and creating a second
pressure differential across the slit valve thereby aspirating
liquids from a patient.
Features from any of the above-mentioned embodiments may be used in
combination with one another in accordance with the instant
disclosure. In addition, other features and advantages of the
instant disclosure will become apparent to those of ordinary skill
in the art through consideration of the ensuing description, the
accompanying drawings, and the appended claims.
BRIEF DESCRIPTION OF THE DRAWINGS
Advantages of the present invention will become apparent upon
review of the following detailed description and drawings, which
illustrate representations (not necessarily drawn to scale) of
various embodiments of the invention, wherein:
FIG. 1 is a front view of a patient with a catheter assembly placed
within a vasculature of the patient;
FIG. 2 is a perspective view of a diaphragm with a slit valve
disposed therein and a valve control member;
FIG. 3 is a perspective view of the diaphragm and valve control
member of FIG. 2 adjacent one another;
FIG. 4 is a perspective of the diaphragm and valve control member
of FIG. 3 illustrating actuation of the valve in a distal
direction;
FIG. 5 is a perspective view of one embodiment of a slit valve;
FIG. 6 is a perspective view of one embodiment of a slit valve;
FIG. 7 is a perspective view of the slit valve of FIG. 6 in a
distally open position;
FIG. 8 is a cross section view of one embodiment of a valve
assembly;
FIG. 9 is a cross section view of one embodiment of a slit
valve;
FIG. 10 is a bottom view of the slit valve of FIG. 9;
FIG. 11 is a cross section view of one embodiment of a slit
valve;
FIG. 12 is a bottom view of the slit valve of FIG. 11;
FIG. 13 is a cross section view of one embodiment of a slit
valve;
FIG. 14 is a cross section view of one embodiment of a slit
valve;
FIG. 15 is a cross section view of one embodiment of a valve
assembly;
FIG. 16 is a top view of one embodiment of a slit valve;
FIG. 17 is a cross section view of the slit valve of FIG. 16;
FIG. 18 is a perspective view of one embodiment of a slit
valve;
FIG. 19 is a cross section view of the slit valve of FIG. 18;
FIG. 20 is a perspective view of one embodiment of a slit
valve;
FIG. 21 is cross section view of one embodiment of a slit
valve;
FIG. 22 is a cross section view of one embodiment of a slit
valve;
FIG. 23 is cross section view of one embodiment of a slit
valve;
FIG. 24 is a cross section view of one embodiment of a slit
valve;
FIG. 25 is cross section view of one embodiment of a slit valve;
and
FIG. 26 is a cross section view of one embodiment of a slit
valve.
DETAILED DESCRIPTION
One aspect of the instant disclosure relates to apparatuses and
systems for pressure-activated valves for use with a medical
device. Specifically, the instant disclosure contemplates that a
slit valve may be disposed within a medical device, such as a
catheter, for selective infusion and aspiration of fluids through
the catheter and into a patient.
Referring to FIG. 1, catheter assembly 10 may be of any type that
can be disposed within a body cavity, duct, or vessel. Examples of
such catheters include, without limitation, peripherally inserted
central catheters, central venous catheters, intravenous catheters,
urological catheters, as well as catheters utilized for
ventilation, pleural drainage, angioplasty, or enteral feeding.
FIG. 1 illustrates a catheter 14 peripherally placed via a
subclavian vein 12. However, catheter 14 can be disposed within any
portion of a patient wherein drainage, injection or aspiration of
fluids, access by surgical instruments, etc. is desired. Catheter
14 comprises a first portion 15 having distal end 20 configured for
placement into a portion of a patient 25 and a proximal end 30
configured for attachment to a valve assembly 35. Catheter assembly
10 further comprises a second portion 40 having a distal end 41
configured for attachment to valve assembly 35 and a proximal end
42 configured for attachment to a fluid source 43 and a fluid
removal and fluid injection location 44.
In one embodiment, fluid may be delivered via catheter assembly 10
to patient 25 via an IV bag connected to a proximal portion of the
catheter assembly 10 wherein the fluid is substantially gravity-fed
to the patient 25. In another embodiment, fluids may be power
injected via the catheter assembly 10 to the patient 25 by
connecting a proximal portion of the second portion 40 of the
catheter assembly 10 to a power injection system. In another aspect
of the invention, fluids may be aspirated by connecting a syringe
to the fluid removal location 44 and applying negative pressure to
the catheter assembly 10.
Generally, one aspect of the invention contemplates a
pressure-activated valve positioned in the flow path of a catheter
inserted into a patient. The valve can be actuated in a distal
direction by a first pressure differential, for example,
gravity-induced pressure from a fluid source, such as an IV bag.
The valve can also be actuated in a distal direction, for example,
by power injection of contrast media into the patient. The valve
can also be actuated in a proximal direction by a second pressure
differential, for example, by negative pressure from a syringe
thereby enabling blood withdrawal from the patient. In one
embodiment, the first pressure differential is less than the second
pressure differential. However, any of the pressure-activated
valves disclosed herein can be reversed thereby changing the
pressure differential paradigm (e.g., the first pressure
differential is greater than the second pressure differential).
Referring now to FIGS. 1 through 4, in one embodiment, a valve
assembly 35 can include a diaphragm 45 with at least one slit valve
50 disposed therein and a valve control member 55 disposed adjacent
the diaphragm 45. By itself, the slit valve 50 is configured to
actuate in both a proximal direction and a distal direction in
response to a proximal pressure or a distal pressure, respectively.
The valve control member 55 is configured to control deflection of
the diaphragm 45 in a proximal direction thereby restricting
actuation of the slit valve 50 in the proximal direction 57. As a
result, when the valve control member 55 is positioned adjacent the
diaphragm 45, the pressure differential which actuates the slit
valve 50 in a distal direction is less than the pressure
differential required to actuate the slit valve 50 in a proximal
direction. In one embodiment, the diaphragm 45 is circular and the
valve control member 50 is correspondingly circular. However, the
diaphragm 45 and valve control member 55 can be oval, rectangular,
or any other suitable shape. The valve control member 55 can be
placed on a distal end of the diaphragm 45, on a proximal end of
the diaphragm 45, or on both ends of the diaphragm 45.
In one aspect of the invention, the valve control member 55
comprises at least one arm 60 extending from an outer portion 65 of
the valve control member 55 to an inner portion 66 of the valve
control member 55. In this aspect of the invention, the arm can
extend laterally across a portion of the face of the diaphragm or
any other angular orientation. In another embodiment, the valve
control member 55 comprises a plurality of arms 60 extending from
an outer portion 65 of the valve control member 55 to a center
portion 66 of the valve control member 55. In one embodiment, a
single slit valve 50 is disposed substantially within the center 75
of the diaphragm 45 and is substantially linear. In another
embodiment several slit valves may be disposed either centrally or
about the periphery of the diaphragm. Additionally, the slit valves
may have a nonlinear orientation or may comprise a plurality of
interconnected linear slits oriented in different directions.
Referring now to FIGS. 1, 5, 6, and 7, in one embodiment, valve
assembly 35 may include a pressure-activated valve 80 having an
open circular proximal end 85 and an at least partially closed
distal end 90. Referring generally to FIG. 5, the distal end 90 of
the valve 80 comprises at least a partially planar surface 82
having slit valves 95 oriented in different directions. The slits
95 have at least one common intersection 100 and are configured to
actuate in a distal direction in response to a first pressure
differential (e.g., less than or equal to approximately 2 psi). A
portion 105 of the distal end 90 of the valve 80 is defined by an
interior angle 110 of the at least two above-referenced slits 95.
An outer portion 115 of the distal end 90 of the valve 80 tapers
from the distal end 90 of the valve 80 towards the proximal end 85
of the valve 80. The tapering of the outer portion 115 of the valve
80 forms a channel 120 on the outer portion 115 of the distal end
90 of the valve 80 in the area defined by the interior angle 110 of
the intersecting slits 95.
As illustrated in FIG. 6, in one embodiment, at least one
proximal-actuating slit valve 125 can be provided on the distal end
90 of the valve 80. The proximal-actuating slit valve 125 can be
configured to actuate in a proximal direction in response to a
second pressure differential (e.g., greater than or equal to
approximately 2 psi), wherein the second pressure differential is
greater than the first pressure differential. As depicted in FIG.
7, the infusion of fluids through the valve 80 results in
deflection of the distal actuating valve 80. In one embodiment, the
deflection of the valve 80 in the distal direction closes the
proximal-actuating valve 125. When the pressure gradient is
reversed (e.g., aspiration is underway), the proximal-actuating
valve 125 is closed. In another aspect, a plurality of
proximal-actuating slits 95 can be disposed on the distal end of
the valve 90 oriented to approximate the shape of a cruciform.
Accordingly, the distal end 90 of valve 80 is separated by the slit
valves into quadrants. In one aspect of the invention, channel 120
can be formed in each quadrant of the valve 80. Moreover, the
proximal-actuating slit 125 can be disposed with the channel 120 of
the valve 80. In an additional embodiment, the valve 80 is
configured such that the center 100 of the cruciform is
approximately collinear with the center of the circular proximal
end 85 of the valve 80. In an additional embodiment, the sum of the
arc lengths 130 of each quadrant is equal to the circumference of
the proximal end 85 of the valve 80. For example, if the arc length
130 of one quadrant is equal to 0.5 inches the circumference of the
proximal end 85 of valve 80 is approximately 2 inches.
Referring now to FIGS. 8 through 10, in one embodiment, a medical
device for regulating fluid flow is disclosed comprising a valve
housing 150 configured to attach to a proximal end of a catheter.
The medical device further comprises a diaphragm 155 with at least
one bidirectional slit valve 160 disposed therein, wherein the
diaphragm approximates a dome structure 165. The slit valve 160 may
have linear or nonlinear orientations. The valve housing 150 is
further configured to secure the diaphragm 155 at a peripheral
portion 170 of the diaphragm 155. A central portion 175 of the
diaphragm 155 is positioned relative to the peripheral portion 170
of the diaphragm 155 such that when the peripheral portion 170 is
secured by the valve housing 150, the compressive forces acting on
the peripheral portion 170 create moment forces which bias the slit
valve 160 in a neutral position. Despite the moment forces which
bias the slit valve 160 in a neutral position, the slit valve 160
is configured to flex in a distal direction in response to pressure
(e.g., a gravity-induced liquid pressure). In one embodiment, the
peripheral portion 170 of the diaphragm has a height which is at
least twice the width of the hinge 171 of the diaphragm 155. In
another embodiment, the height of the peripheral portion 170 is
approximately twice the width of the peripheral portion. In yet
another embodiment, the peripheral portion 170 is compressed by the
valve housing approximately five to 15 percent. In one embodiment,
the peripheral portion 170 of the diaphragm 155 has a height that
ranges from approximately 0.005 inches to 0.075 inches and a
thickness of the central portion 175 of the diaphragm 155 ranges
from approximately 0.001 to 0.003 inches.
Referring generally to FIGS. 1 and 8 through 12, in one embodiment,
the valve housing 150 comprises a distal end 185 having a central
hollow portion 190 configured to connect to a proximal end of a
first portion of catheter assembly 10, a distal end 20 of the first
portion 15 of catheter assembly 10 is configured for placement into
a vasculature of a patient 20. The valve housing 150 further
comprises a proximal portion 195 having a central hollow portion
200 configured to connect to a distal end 41 of a second portion 40
of catheter 10. A proximal end 42 of the second portion 40 of
catheter assembly 10 is configured to connect to a fluid source 43
and also connect to a fluid removal and fluid injection location
44. The distal portion 185 and proximal portion 195 of the valve
housing 150 mate at complimentary cut-away areas 205 securing the
diaphragm 155 therebetween. All or part of the peripheral portion
170 of the diaphragm 155 may be secured by the valve housing 150
depending on the desired moment forces resulting from compression
of the peripheral portion 170. The distal portion 185 and proximal
portion 195 of the valve housing 155 can be secured together
through any suitable method (e.g., bonded or welded). In one
embodiment, as illustrated in FIG. 8, the diaphragm 155 is secured
such that it is perpendicular to the flow of fluid through the
valve housing 150. The diaphragm 155 may be substantially circular,
oval, rectangular, or any other suitable shape.
In another embodiment, the diaphragm 155 further comprises at least
one arm or protrusion 210. The protrusion 210 may be placed on a
proximal end of the diaphragm 155 to assist the slit valve 160 to
return to a neutral position after aspiration. When the slit valve
160 opens during aspiration, the protrusion 210 contacts the valve
housing 150 thereby creating a moment force opposite the direction
of contact to assist the slit valve 160 to return to a neutral
position after aspiration. Multiple protrusions may be added in
different embodiments on both distal and/or proximal ends of the
diaphragm 155 to optimize valve function.
In another embodiment, the diaphragm 155 is configured such that a
portion of the proximal end of the diaphragm contiguous with the
slit valve is thinner than an adjacent portion of the diaphragm.
The thinner area 215 near the slit valve 160 assists in actuation
of slit valve 160 as well as slit valve performance during gravity
flow of fluids through the diaphragm 155. In areas where the
diaphragm is thinner, the diaphragm may be reinforced as
illustrated in FIG. 9. The reinforced area 220 assists in returning
the slit valve 160 to a neutral position by distributing moment
forces coming from protrusion 210. Additionally, the reinforced
area 220 provides a secondary sealing surface 225 for an opposing
valve face 230 in the event that the slit valve 160 is unable to
return to a neutral position. In another aspect, the diaphragm 155
is configured such that valve hinge 171 is thinner than an adjacent
portion of diaphragm 155. The thinner area near of valve hinge 171
facilitates hinge activity under lower pressures (e.g.,
gravity-induced pressure).
As illustrated in FIGS. 11 and 12, in one embodiment, the diaphragm
155 comprises a plurality of unidirectional slit valves. The
diaphragm 155 can have a distal-actuating slit valve 240 disposed
in a central region of the diaphragm 155 and at least one
proximal-actuating slit valve 245 disposed on a lateral portion of
the diaphragm 155. The distal-actuating slit valve 240 flexes in
response to infusion-induced pressures and remains closed during
aspiration. The at least one proximal-actuating slit valve 245
flexes in response to aspiration-induced pressures and remains
closed during infusion procedures.
Referring to FIGS. 13 and 14, in one embodiment of the present
invention, a diaphragm 250 is disclosed having at least one
bidirectional slit valve 255 disposed therein. The diaphragm 250
approximates a dome structure 260. The diaphragm 250 further
comprises an annular member 265 which circumscribes the dome
structure 260. In one embodiment, the annular member 265 is
oriented with its apex 270 in a proximal direction. In another
embodiment, the annular member 265 is oriented with its apex 275 in
a distal direction.
Referring now to FIGS. 1 and 15 through 17, in one embodiment, a
valve assembly is disclosed comprising a valve housing 300
configured to secure a diaphragm 305 at a peripheral portion 310 of
the diaphragm 305. The diaphragm 305 has at least one slit valve
315 disposed therein and is oriented within the valve housing 300
at a direction which is at an obtuse angle relative to the
direction of fluid flow through the valve housing 300. The valve
housing 300 comprises a distal end 320 having a central hollow
portion 325 configured to connect to a proximal end 30 of a first
portion 15 of catheter assembly 10. A distal end 20 of the first
portion 15 of catheter assembly 10 is configured for placement into
a vasculature 12 of patient 25. The valve housing 300 further
comprises a proximal portion 330 having a central hollow portion
335 configured to connect to a distal end 41 of a second portion 40
of catheter assembly 10. A proximal end 42 of the second portion 40
of catheter assembly 10 is configured to connect to a fluid source
43 and also connect to a fluid removal and fluid injection location
44. The distal portion 320 and proximal portion 330 of the valve
housing 300 mate at complimentary cut-away areas 340 securing the
diaphragm 305 therebetween. All or part of the peripheral portion
310 of the diaphragm 305 may be secured by the valve housing 300
depending on the desired moment forces resulting from compression
of the peripheral portion 310. The diaphragm 305 can have a
substantially circular shape, a substantially oval shape, a
substantially rectangular shape, or any other suitable shape, and
can also approximate a dome structure. The distal portion 320 and
proximal portion 330 of the valve housing 300 can be secured
together through any suitable method (e.g., bonded or welded). In
another embodiment, the surface area of diaphragm 305 subjected to
pressure actuation (e.g., not in contact with any portion of the
valve housing 300) is greater on a proximal end of the diaphragm
305 than a distal end of the diaphragm 305. The amount of the slit
valve 315 disposed in diaphragm 305 that is subject to pressure
actuation (e.g., not in contact with any portion of the valve
housing 300) is equal on both distal and proximal ends of the
diaphragm 305. This can be accomplished by varying the shape or
size of the distal portion 320 and proximal portion 330 of valve
housing 300.
Referring now to FIGS. 18 and 19, in an additional embodiment, the
diaphragm narrows from a lateral portion 345 of the diaphragm 305
to an opposite lateral portion 350 of the diaphragm 305. In another
embodiment, the diaphragm 305 has two slit valves 355 disposed on
opposing sides of the diaphragm 305. Each slit valve 355 is
unidirectional. A first valve is configured to actuate in a distal
direction in response to an infusion-induced pressure differential.
A second valve is configured to actuate in a proximal direction in
response to an aspiration-induced pressure differential. The
relative thickness of lateral portions of diaphragm 305 control the
actuation pressure of the slit valves 355.
Referring now to FIG. 20, in an additional aspect, a medical device
for regulating fluid flow is disclosed comprising a generally
cylindrical member 370 having a closed distal end 375 and an open
proximal end 380. The proximal end 380 further comprises a shoulder
member 385 configured to be secured at least partially by a valve
housing. The cylindrical member 370 has at least one slit valve 390
disposed therein being oriented parallel to a longitudinal axis of
the cylindrical member 370. In another aspect, the cylindrical
member 370 further comprises a plurality of slit valves 390
disposed on the cylindrical member 370.
Referring generally to FIGS. 21 and 22, a diaphragm 400 for
regulating fluid flow is disclosed having at least one slit valve
405 disposed therein. The diaphragm 400 can be secured in a valve
housing at a peripheral portion 410 of the diaphragm. In this
embodiment, a proximal surface 415 of the diaphragm 400 is
substantially planar. Likewise, a distal surface 420 of the
diaphragm 400 is substantially planar. A central portion 420 of the
diaphragm 400 is thinner than an outer region 425 of the diaphragm
400. In another embodiment, the distal surface 430 of the diaphragm
400 is substantially planar and the proximal surface is
substantially conical 435. In another embodiment, referring
generally to FIGS. 23 and 24, the proximal surface 440 of the
diaphragm 400 is substantially planar and the distal surface of the
diaphragm 400 approximates a spherical cap 445. In another
embodiment, the distal surface 450 of the diaphragm 400
approximates a spherical cap and the proximal surface 455 of the
diaphragm 400 also approximates a spherical cap. The virtual
centers of the opposing spherical caps of the diaphragm 400 can be
collinear. The spherical cap on the distal surface 455 can be
smaller than the spherical cap on the proximal surface 450. In yet
another embodiment, referring generally to FIGS. 25 and 26, a
proximal surface 460 of the diaphragm 400 is substantially conical.
The distal surface 465 of the diaphragm 400 is also substantially
conical.
The diaphragms discussed herein can be molded in one piece from an
elastomeric material (e.g., a silicone rubber having a Shore A
Durometer rating from about 30 to 60). It should be noted that any
of the diaphragms discussed herein can be manufactured from any
elastomeric material including, without limitation, polyisoprene,
butyl rubber, halogenated butyl rubbers, polybutadiene,
styrene-butadiene rubber, nitrile rubber, hydrated nitrile rubbers,
Therban.RTM. elastomer, Zetpol.RTM. elastomer, chloroprene rubber,
polychloroprene, neoprene, baypren, EPM (ethylene propylene rubber,
a copolymer faeces of polyethylene and polypropylene), EPDM rubber
(ethylene propylene diene rubber, a terpolymer of polyethylene,
polypropylene and a diene-component), epichlorohydrin rubber,
polyacrylic rubber, fluorosilicone rubber, fluoroelastomers,
Viton.RTM. elastomer, Tecnoflon.RTM. elastomer, Fluorel.RTM.
elastomer, Dai-El.RTM. elastomer, perfluoroelastomers, tetrafluoro
ethylene/propylene rubbers, chlorosulfonated polyethylene,
Hypalon.RTM. elastomer, ethylene-vinyl acetate, Hytrel.RTM.
elastomer, Santoprene.RTM. elastomer, polyurethane rubber, resilin,
elastin, and/or Polysulfide rubber.
The valve housings discussed herein can be molded in one or more
pieces from a thermoplastic material (e.g., a polyethylene
terephthalate having a Shore A Durometer rating from about 60 to
85). It should be noted that any of the valve housings discussed
herein can be manufactured from any thermoplastic material
including, without limitation, acrylonitrile butadiene styrene,
acrylic, celluloid, cellulose acetate, ethylene-vinyl acetate,
ethylene vinyl alcohol, fluoroplastics, ionomers, polyacetal,
polyacrylates, polyacrylonitrile, polyamide, polyamide-imide
polyaryletherketone, polybutadiene, polybutylene, polybutylene
terephthalate, polyethylene terephthalate, polycyclohexylene
dimethylene terephthalate, polycarbonate, polyhydroxyalkanoates,
polyketone, polyester, polyethylene, polyetheretherketone,
polyetherimide, polyethersulfone, polyethylenechlorinates,
polyimide, polylactic acid, polymethylpentene, polyphenylene oxide,
polyphenylene sulfide, polyphthalamide, polypropylene, polystyrene,
polysulfone, and/or polyvinyl chloride.
Any of the catheters described herein can be manufactured from any
biocompatible material suitable for placement into a portion of a
patient.
Although the above-described embodiments show a particular
configuration of a pressure-actuated valve and valve assembly, such
embodiments are exemplary. Accordingly, many different embodiments
are contemplated and encompassed by this disclosure. It should also
be understood that the device and method for controlling fluid flow
through a catheter can be used with any method or device wherein
fluids are administered to or removed from a patient.
While certain embodiments and details have been included herein for
purposes of illustrating aspects of the instant disclosure, it will
be apparent to those skilled in the art that various changes in the
systems, apparatuses, and methods disclosed herein may be made
without departing from the scope of the instant disclosure, which
is defined, in part, in the appended claims. The words "including"
and "having," as used herein including the claims, shall have the
same meaning as the word "comprising."
* * * * *
References